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EC number: 216-407-3
CAS number: 1576-35-8
Table 1 Summary of microscopic findings
Dose of OBSH (mg/kg/day)
Number of Animals
This study was conducted to investigate the potential toxicity of
4,4’-Oxybis(benzenesulfonyl hydrazide) (OBSH) in Sprague-Dawley (SD)
rats following 13 weeks of treatment by oral gavage administration. OBSH
was administered once daily to SD rats for 13 weeks (approximately
90-days). The animals were assigned to 4 groups (10 animals/sex/group)
receiving test item at dose levels of 0, 2, 10 and 50 mg/kg. Following
final dosing on Day 91 (male) or 92 (female), all animals were
necropsied on Day 92 (male) or 93 (female).
Observations for mortality, morbidity, general appearance and
behaviour changes were recorded twice daily for all animals during the
treatment period. Body weight and food consumption were measured once
weekly until terminal sacrifice. Terminal body weight was measured
before necropsy. Ophthalmic examinations were conducted once prior to
the initiation of treatment and then prior to the terminal necropsy.
Also an abbreviated neurobehavioral test battery, consisting of selected
functional observational battery assessments (FOB) and motor activity
(MA), was conducted prior to the terminal necropsy. Blood samples for
the hematology, clinical chemistry and urinalysis were collected from
all animals at the terminal necropsy. At the sacrifice, macroscopic
examinations were performed; organ weights recorded and collected
tissues for microscopic examination.
No test item-related mortality, body weight and food consumption
changes, abnormalities in ophthalmology, urinalysis/urine chemistry and
abbreviated neurobehavioral test battery and macroscopic observations
were observed in this study. Test item-related salivation was observed
at≥10 mg/kg in both sexes but resolved before the next dosing.
In hematology, absolute and relative reticulocytes in both sexes
and absolute and relative neutrophil counts in females were increased at
50 mg/kg/day. In clinical chemistry, aspartate aminotransferase (AST) at
50 mg/kg/day and alanine aminotransferase (ALT) at 10 and 50 mg/kg/day
were decreased in both sexes. Increases in total bilirubin (TBIL),
triglyceride (TG), inorganic phosphorus (IP) and potassium (K) and a
decrease in glucose (GLU) were observed in females at 50 mg/kg/day.
In organ weights, statistical and significant increased kidneys
and liver weights, both absolute and relative, were observed in both
sexes at 50 mg/kg/day. These organ weight changes were not supported
with histopathological changes. In spleen, minimally increased
extramedullary hematopoiesis (EMH) was observed in both sexes at 50
mg/kg/day. This change was associated with an increase of reticulocyte.
It was considered test item-related changes, but not considered adverse.
In conclusion, daily oral administration of
4,4’-Oxybis(benzenesulfonyl hydrazide) (OBSH) to SD rats at 0, 2, 10 and
50 mg/kg bw/d for 13 weeks resulted in organ weight changes (kidney and
liver), histopathological changes (EHM) in the spleen and changes in
haematological and clinical chemistry parameters at 50 mg/kg bw/d.
Based on these results, NOAEL was considered to be 10 mg/kg in
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